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Complications Following Bilateral Prophylactic Mastectomy
Affiliations of authors: Department of Ambulatory Care and Prevention, Harvard Pilgrim Health Care, Boston, MA (MBB, LN, SWF); Southern California Kaiser Permanente, Research and Evaluation Department, Pasadena, CA (CNW, I-LAL, AMG); Kaiser Permanente Center for Health Research, Portland, OR (ELH); HealthPartners, Minneapolis/St Paul, MN (SJR); University of Washington, Division of General Internal Medicine, Seattle, WA (JGE); Northern California Kaiser Permanente, Division of Research, Oakland, CA (LJH); Group Health Cooperative, Seattle, WA (SMG)
Correspondence to: Mary B. Barton, MD, MPP, Department of Ambulatory Care and Prevention, 133 Brookline Ave., 6th Floor, Boston, MA 02215 (e-mail: mary_barton{at}hms.harvard.edu).
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ABSTRACT |
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Background: Bilateral prophylactic mastectomy significantly decreases breast cancer risk, but complications of the procedure have only been described in single-site studies. We describe the frequency and type of complications in women who underwent bilateral prophylactic mastectomy in a multisite community-based cohort. Methods: Women aged 18–80 years undergoing bilateral prophylactic mastectomy without a personal history of breast cancer at one of six health plans were eligible. We identified women from automated data sources, then reviewed hospital data, ambulatory notes, and other chart elements to confirm eligibility and obtain all charted information about complications and surgeries performed after prophylactic mastectomy, including reconstructive procedures. Reconstructions were characterized by type (implant vs. tissue graft). Complications were noted for a 1-year period after any surgical procedure. Results: We identified 269 women with prophylactic mastectomy who were followed for a mean of 7.4 years. Their mean age was 44.9 years. Nearly 80% undertook reconstruction, most with prosthetic implants. One or more complications occurred in 64%. The most common complications were pain (35% of women), infection (17%), and seroma (17%). Women with no reconstruction had fewer complications (mean of .93) than women who had implant (2.0) or tissue graft (2.4) reconstruction procedures (differences from no reconstruction: 1.07 [95% confidence interval = 0.36 to 1.77] and 1.50 [95% confidence interval = 0.44 to 2.56] respectively). Delay of reconstruction after mastectomy was associated with a borderline-significant higher risk of complications (80.6%) compared to simultaneous reconstruction (64.0%, P = .055). Conclusion: We found that almost two-thirds of women undergoing bilateral prophylactic mastectomy had at least one complication following surgery. Further work should be done to minimize and to understand the effect of complications of bilateral prophylactic mastectomy.
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INTRODUCTION |
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Studies of bilateral prophylactic mastectomy report a greater than 90% reduction in subsequent breast cancer incidence and death (1–4). As media attention and the use of genetic testing for breast cancer susceptibility increases (5,6), the number of women who consider the procedure also will likely increase. However, there are limited data describing the surgical complications of bilateral prophylactic mastectomy, an important feature for women considering the procedure. Furthermore, all six previously published reports come from four single-site, academic centers (7–12). We present the results of a study conducted at six community-based health plans across the United States, aimed at determining the frequency and types of complications following bilateral prophylactic mastectomy surgery, with or without reconstruction.
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Methods |
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Design and Setting
We conducted a retrospective cohort study to determine the complications of bilateral prophylactic mastectomy in community-based settings. The cohort (described in detail elsewhere) (4) was identified from the membership of six health plans with over 7.3 million enrollees as of 2000. The study was carried out under the auspices of the Cancer Research Network (CRN), a consortium of research organizations affiliated with nonprofit integrated health care delivery systems and funded by the National Cancer Institute.
The participating health plans in this study were Group Health Cooperative, WA; Harvard Pilgrim Health Care, MA; HealthPartners, MN; and three Kaiser Permanente regions: Northwest (Oregon) and Northern and Southern California. Each site received Institutional Review Board approval in accord with assurances filed with and approved by the U.S. Department of Health and Human Services. The requirement for informed consent was waived.
Subjects
Eligible women included health plan enrollees aged 18–80 years during 1979 to 1998 (1981–1998 at one site) who underwent simultaneous bilateral prophylactic mastectomy. Bilateral prophylactic mastectomy was defined as a simultaneous bilateral subcutaneous or more extensive mastectomy in the absence of a breast cancer diagnosis. Potentially eligible women were identified from hospitalization data. Women with a personal history of breast cancer were identified from cancer registry (four sites) or ambulatory (two sites) data and excluded.
Data Elements
Subject eligibility and information on surgical breast procedures and complications were verified via review of medical records containing hospital discharge summaries, operative notes, and pathology reports, as well as ambulatory progress notes and other chart elements. Data were recorded on a pretested data collection form on laptop computers, using software preprogrammed with the capacity for immediate checks for range and consistency (13). Medical record abstractors were trained using a printed manual and video followed by an extensive training period. An ongoing, validated quality control program (14) included regular conference calls of all abstractors and monthly reabstraction of a random sample of medical records.
We gathered information on all surgical breast procedures performed on and after the date of the prophylactic mastectomy and on any complications of surgery for a period of 1 year after the mastectomy and also after each subsequent breast surgical procedure. Tracked surgical procedures included prophylactic mastectomy, any reconstruction and any revisions up until either the last chart date or the end of follow-up for the cohort on December 31, 1999, whichever came later. For each woman, the presence or absence of reconstructive surgery during the follow-up period was noted. For women with reconstructive procedures we also determined the type of initial reconstruction procedure (autogenous tissue graft or prosthetic implant) and timing of reconstructive procedure (immediate, defined as within 2 days of prophylactic mastectomy, or delayed). Women who ultimately underwent more than one type of reconstruction were categorized according to their first reconstruction attempt.
Complications were recorded by medical record abstractors onto a list of more than 25 complications generated from review of the literature and consensus. These individual complications including surgical, medical, and emotional conditions were then grouped into categories of clinical similarity by a panel of four clinicians (MB, JE, LN, SF). Complications were divided by region (local versus systemic) and by type. The categories were local, limited complications (e.g., hemorrhage, or wound infection); local complications that might require revision to repair (e.g., excessive scarring, flap necrosis); local complications of a permanent or irreversible nature (e.g., lymphedema); and systemic complications (e.g., fever, mental health, hematological, vascular, and postoperative complications such as urinary retention). The same complication occurring twice or more within a 14-day period was counted only once.
Statistical Analysis
Characteristics of women in our study population were described according to race, year of prophylactic mastectomy, length of follow up, health plan, and age. The timing of reconstruction among women with different types of initial reconstructive procedure and the proportion of women with one or more complications among women with different types and timing of reconstructive procedure were compared using chi-square. The number of complications per woman was compared using t tests. Mean numbers of reconstruction-associated procedures were compared among women with different types of reconstructive procedures, using ANOVA. Bivariate associations of the type and timing of reconstruction as well as patient characteristics with the presence or absence of complications were evaluated with chi-square and logistic regression; multivariable logistic regression examined the simultaneous independent association of several variables on the risk for having a complication. All statistical tests were two-sided; analyses were performed using SAS software (Version 8.2, Cary, NC).
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RESULTS |
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We identified 269 women who had bilateral prophylactic mastectomies in the six health plans during the years of the study (Table 1). The mean age of women at the time of the procedure was 44.9 years (range: 23–74), and the mean length of follow-up after the prophylactic mastectomy was 7.4 years (range: 7 weeks to 20.3 years). The majority (90.3%) were Caucasian. Most women who underwent prophylactic mastectomy also had a surgical reconstructive procedure performed (79.5%), most commonly using prosthetic implants (186, 69.1% of the cohort), with only 28 women (10.4%) undergoing autogenous tissue graft procedures (e.g., TRAM flaps). Initial surgical reconstructions were performed simultaneously with the prophylactic mastectomy for 178 (66%) women and after the prophylactic mastectomy for 36 (13%). The type of initial surgical reconstructive procedure was not associated with the timing of the reconstructive procedure (p = .66, chi square).
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Almost two-thirds (64%) of the women undergoing bilateral prophylactic mastectomy had at least one complication following breast surgery (after either the prophylactic mastectomy procedure itself or a subsequent reconstructive procedure). Table 2 shows specific complications noted in the medical records: 63% of women experienced one or more local complications. The most common local, but limited, complication (and most common overall) was pain (36% of women), followed by infection (17%) and seroma or leakage of lymphatic fluid (17%). Pain was documented a median of 10 days after women's most recent surgery (range: 0–366 days). Local complications that might require revision to repair occurred in 73 women (27%). Systemic complications occurred in 12% of women. Mental health complications such as depression, anxiety, and breast cancer worry were documented in charts infrequently but were noted in 11 (4%) women. Nine (3.3%) women developed lymphedema, and disseminated intravascular coagulation and anesthesia-related shock occurred in one woman (0.4%) each. No woman died of complications.
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Complications occurred in more than half of women who had no reconstructive procedure (53%), a proportion lower than that among women undergoing autogenous tissue graft reconstruction (75%, P = .04) but not significantly different from women with prosthetic implant reconstruction (66%, P = .08) (Table 3). The mean number of complications per woman was 1.8 (range: 0–15). Women with no reconstruction had on average fewer complications (.93) than women who had implant (2.0) or tissue graft (2.4) reconstruction procedures (differences from no reconstruction: 1.07 [95% confidence interval {CI} = 0.36 to 1.77] for implant and 1.50 [95% CI = 0.44 to 2.56] for tissue graft. The difference between the two reconstruction types was not significant [difference in means between reconstruction types: .43 (95% CI = –0.49 to 1.36)].
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Complications occurred more often in women with delayed reconstruction than those with simultaneous reconstruction (80.6% vs. 64.0%), although this difference was of borderline statistical significance (P = .055). Neither the absence nor type of reconstructive surgery was associated with the occurrence of specific subsets of complications (P = .24) (Table 3). Timing of reconstruction was also not associated with a significant difference in the distribution of local versus systemic types of complications (P = .42, data not shown) but a difference of borderline significance was seen in the proportion of complications that were deemed to potentially require repair, or to be irreversible (35% of complications in women with delayed reconstruction versus 29% in women with simultaneous reconstruction and 16% with no reconstruction; P = .051). The potential association between delayed reconstruction and increased risk of complications is not apparently explained by complications that were noted on the date of the prophylactic mastectomy, as the proportion of women with delayed reconstruction with complications on the date of their prophylactic mastectomy (5.6%) was about half the proportion of women with simultaneous reconstruction (11.8%) with complications on that day (chi-square, P = .29). This finding is not surprising given that women without reconstruction undergo only one procedure at the time of prophylactic mastectomy, whereas women with simultaneous reconstruction in essence undergo two procedures in 1 day.
Table 3 shows the number of women undergoing further surgical procedures, including any reconstructive procedures done on the same day or after the bilateral prophylactic mastectomy, whether planned (as in staged reconstruction procedures) or unanticipated. The mean number of postbilateral mastectomy procedures for women undergoing no reconstruction was .27, compared to 5.6 for women with implants and 6.7 for women with tissue grafts. Eighty-seven percent (48/55) of women with no reconstruction had no subsequent surgical procedures; in contrast, 47% of women with tissue grafts and 25% of women with implants had eight or more subsequent procedures.
The median length of time between the bilateral prophylactic mastectomy and the first complication noted in the medical record was 11.5 days, with a range from 0 to 5061 days (more than 13 years, reflecting the fact that many women had reconstruction-related surgeries and were therefore followed long after the initial bilateral prophylactic mastectomy). Sixty-eight percent of complications occurred within 30 days of the most recent surgery, and 86% within 90 days. The median time from the prophylactic mastectomy to the last recorded complication was 145 days for the women with complications (range: 0–5767 days, nearly 16 years).
More than 10% (32/269) of women had at least one complication that was noted on more than one occasion, and thus potentially chronic; the median time between first and last chart mentions of the 50 complications noted two or more times was 443 days (range: 29–5283 days, or 14.5 years). The most common of these complications was pain, representing 21 of 50 "chronic" complications; the median time between first and last chart mentions of pain was 341 days (range: 76–15.6 years). The length of time between first and last mention of a complication was not associated with the timing of reconstructive procedure (data not shown) but was longer on average for women with implant reconstruction (1190 days) than with tissue graft reconstruction (222 days; difference between means 967 days, 95% CI = 126 to 1809).
In Table 4 we show the bivariate and multivariate associations with the presence of one or more complications. Several attributes we examined were not related to the odds of having a complication in unadjusted analyses, including age, year of prophylactic mastectomy, race, and length of follow-up time. Timing of reconstructive procedure was significantly associated with the risk of complication (odds ratio [OR] for delayed reconstruction compared to no reconstruction 3.71, 95% CI = 1.39 to 9.90), whereas the OR for simultaneous reconstruction compared to no reconstruction, 1.6 (95% CI = 0.87 to 2.94) was not significant. Type of reconstructive procedure was indicative of a difference, though not significantly, with an OR for graft reconstruction compared to no reconstruction of 2.7 (95% CI = 0.98 to 7.4), and an OR for implant reconstruction of 1.7 (95% CI = 0.9 to 3.1).
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We performed multivariable regression models to assess the independent association of reconstructive surgery procedure with the odds of a complication. In Table 4, we show the results of a model containing type of reconstructive procedure as well as age, race, year of prophylactic mastectomy, and health plan, in which the two reconstructive procedures had odds ratios greater than one (adjusted OR for tissue graft 2.2, 95% CI = 0.7 to 6.4; adjusted OR for implant 1.7, 95% CI = 0.9 to 3.3), although not statistically significant. In the multivariate model the risk of complications was not associated with patient age or race, or year of prophylactic mastectomy. A second regression model included timing of reconstruction (data not shown). Delayed reconstruction was associated with an increased risk of complications (adjusted OR 3.7, 95% CI = 1.4 to 9.9), while simultaneous reconstruction was not different from no reconstruction (adjusted OR 1.6, 95% CI = .9 to 2.9). In this model, the earliest time period for year of prophylactic mastectomy procedure (1979–1984) when compared with the latest time period, had a protective odds ratio of 0.41 (95% CI = 0.17 to 0.98); the other time periods show a trend toward increasing odds of complications with odds ratios of 0.53 for the period 1985–1989 (95% CI = 0.23 to 1.25), and 0.89 for the period 1990–1994 (95% CI = 0.41 to 1.90), although neither of these time periods is significantly different from the referent time period (1995–1999).
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DISCUSSION |
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TopNotesAbstractIntroductionMethodsRESULTSDISCUSSIONReferences |
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We found that almost two-thirds of women undergoing bilateral prophylactic mastectomy had at least one complication in the years following surgery. The rate was substantial for women who did not undergo reconstruction (53% had complications, an average of 0.9 per woman) and higher for those who underwent breast reconstruction (66%–75% had one or more complications, depending on type of reconstruction, or an average of 2–2.4 complications per woman). Most of the complications occurred within a month of a surgical procedure (and half of the instances of pain as a complication happened within 10 days), but complications, including pain, persisted in some cases for years. Most complications were local and self-limited, though lymphedema, a serious and permanent complication, occurred in nine women (3%).
Our study is the first that we know of to report on complications after bilateral prophylactic mastectomy from more than a single center and the first to include nonacademic settings. In previously reported series, the frequency of complications after bilateral prophylactic mastectomy ranged from 14% (12) to around 30% (8,11)—complication rates substantially lower than ours. It is possible that the actual complication rates of community surgeons in our study may be higher than those of subspecialists practicing in tertiary- or quaternary-care centers, or of surgeons performing a high volume of bilateral prophylactic mastectomy procedures. Complication rates for many surgical procedures are lower for surgeons and centers that perform a higher volume of the procedure (15,16).
However, the literature in this area is difficult to compare, in part because not all previous series separate bilateral prophylactic mastectomy from mastectomies performed on women with cancer (7,11,12,17). Furthermore, data may not be comparable because of different definitions of complications. For example, Zion et al limited their definition to complications resulting in reoperation (10). Timeframes for data gathering also differed. For example, because we gathered data on complications after any postprophylactic mastectomy breast-related surgery, and for a full year after each surgery, our rates of complications would be expected to be higher than that found in studies that followed women for a shorter period of time, and only after the initial surgery (12). One series that followed patients for 6 months reported that 13.3% of women with bilateral prophylactic mastectomy had complications (9), whereas patients undergoing implant reconstruction following bilateral prophylactic mastectomy at the Mayo Clinic accumulated more complications over time: from 17.3% at 1 year to 30.4% at 5 years (8).
Our findings are consistent in several ways with a recent series comparable to our own. Zion et al studied 593 women who underwent bilateral prophylactic mastectomy with and without reconstruction, using unanticipated reoperation as an outcome (10). The researchers found no association between age and reoperation. Their cohort, covering years from 1975 to 1993, showed a significant trend for more reoperations in women undergoing bilateral prophylactic mastectomy in more recent years, a finding also indicated by the results of our study. It is possible that the increasing complexity of reconstruction procedures, or an increasing number of surgeons involved in these operations, has contributed to an increased risk of complications over time.
The number of procedures undergone by women in our cohort after prophylactic mastectomy indicates a significant number of "revision" procedures. A woman undergoing postprophylactic mastectomy implant reconstruction could undergo as many as six planned surgical procedures (initial placement of expander, followed after serial inflations by replacement of expander with final implant material and nipple reconstruction, each performed on both breasts). Thus, our finding that 25% of women with implants had seven or more subsequent surgical procedures following their bilateral prophylactic mastectomy indicate that one-quarter of these women had unanticipated procedures. In Zion et al's series, unanticipated reoperation within one year occurred in 27.5% of women with bilateral prophylactic mastectomy who underwent implant reconstruction [and less frequently in women with bilateral prophylactic mastectomy who did not undergo reconstruction (12.8%)]. These findings are consistent with ours.
A series of 139 women with bilateral prophylactic mastectomies published in 1987 reported specific complications in a time period of 5 years or more (12). In this cohort, nine (6.5%) women had nipple necrosis, six (4.3%) hematoma, five (3.6%) pain, and two (1.4%) infection, and nine (15%) of 60 who had implant reconstruction had "excessive capsule formation." The rates of nipple necrosis and of capsular contraction (higher than those seen in our study) have almost certainly fallen over the interceding time because of improvements in reconstructive techniques and materials. In contrast, the lower rates of hematoma, pain, and infection in the older study may reflect a truly lower rate in the hands of two highly experienced surgeons, or they could reflect a difference in ascertainment, as the authors did not report the methods of data collection. Differential ascertainment or documentation could also contribute to the appearance of a temporal trend of increasing complications noted in one of our multivariable analyses. Finally, our finding of nine cases of lymphedema in 239 women undergoing bilateral prophylactic mastectomy is not paralleled in the other literature that we found, some of which omitted complications that did not result in reoperation (8,10). Other series may have been too small to detect this complication (9,11,12).
We could find no specific information on complication rates in cancer-free women undergoing tissue graft reconstruction after bilateral prophylactic mastectomy. Published series of patients undergoing tissue graft reconstruction, most of whom had reconstruction after mastectomy for cancer, report tissue flap complications ranging from 23.7% (18) to 38% (17). The complications we designated as "local, and may require revision" (21% of women with tissue graft reconstruction) are likely to approximate the tissue flap complications reported in the previously mentioned series, and are comparable to these rates. The possibility of an increased risk of complications with tissue graft reconstruction compared to implant reconstruction has biologic plausibility, as two distinct surgical sites are involved in tissue graft (donor site and area of reconstruction), compared to only one surgical site for implant reconstruction. However, the implant represents a long-term foreign body, whereas tissue graft reconstruction does not include that risk. Our data indicate that the balance of these competing risks seems to come out even, or with a slight advantage for implant reconstruction.
Our multivariate analysis indicates that patient information available in this study is not useful in predicting risk of complications. We were not able to control simultaneously for the timing and type of reconstruction; because of the small cell sizes, a model including both variables would not converge. Furthermore, the association of the timing of reconstruction with the complication rate may have been confounded by indication. For example, the reason for delay in reconstructive surgery may have been clinical status of the patient that also contributed to risk of complication after surgery. Because we could not untangle that association in our data, we present in Table 4 only the multivariate model including type of reconstruction.
Our study has several strengths. We included all eligible women receiving bilateral prophylactic mastectomy from six large health plans in different parts of the country; thus, our observations provide data that complement those from specialty centers and are particularly relevant to women who do not receive care at such centers. Because our study included multiple clinical sites that were almost entirely nonacademic, the results are likely more applicable to community practices than previous studies from single academic centers and are thus of greater use to women considering bilateral prophylactic mastectomy outside the specialty clinic context. A number of different surgeons were represented in our cohort, increasing the likelihood that several variations in surgical technique were represented. A limitation of our study is that because we used chart review we lacked data directly from patients to assess the physical or emotional effect of these complications. Chart review could undercount some particularly mild complications experienced by patients but not documented by providers. However, it is possible that patients thought that most of the complications were minor compared to their concerns about breast cancer. The earliest prophylactic mastectomies in our study were performed more than 20 years ago, and we would expect that surgical techniques have developed during that time period to make the surgeries performed now safer than those observed in our study. However, the temporal trend in our multivariable model, and the findings of Zion (10), indicate that complication rates are on the rise rather than decreasing.
Patients who choose to undergo bilateral prophylactic mastectomy or reconstruction after prophylactic mastectomy should do so after careful consideration of their options. They deserve to have the most accurate information available to them to assess the potential harms, as well as the benefits, of this procedure. In our study, we found that about two-thirds of women undergoing bilateral prophylactic mastectomy experience complications, with complications more common among women undergoing reconstruction. Further work should be done to minimize and to understand the effect of complications of bilateral prophylactic mastectomy.
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NOTES |
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Presented May 14, 2004 at the Society for General Internal Medicine's 27th Annual Meeting, Chicago, IL.
This study was funded by the National Cancer Institute (5U19 CA79689, Edward H. Wagner MD, MPH Principal Investigator).
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